The company completed a successful phase II meeting with FDA at the end of 2015 for trabodenoson, an agent which appears to treat both the pathophysiology of elevated IOP and the neural damage that can result for excessive IOP.
“We have the opportunity to treat glaucoma in two synergistic ways, the plumbing and electrical pathways,” said Cadmus Rich, MD, vice president of medical affairs and clinical development. “On the plumbing side, we treat the loss of normal IOP regulation at the trabecular meshwork resulting in an increase in IOP. On the electrical side, we treat the pathology common to all glaucoma patients, the neuropathy that disrupts the relaying of the visual signal.”
A trabodenoson-monotherapy program is in phase III with top-line data expected toward the end of 2016. A fixed-dose combination of trabodenoson plus latanoprost is in phase II with top line data expected during the first half of 2017.
Efficacy increases with both dose and time, Dr. Rich said. Trials have not shown any dose-limiting toxicity. The maximum tolerated dose has not yet been determined and there have been no treatment-related dropouts in any clinical trials.